All studies
RecruitingNAINTERVENTIONAL

Tight Control for Rotator Cuff Tendinopathy

This research is investigating if a closer, more frequent check-up schedule helps people with new shoulder pain, specifically rotator cuff tendinopathy, recover better. One group will have monthly appointments for three months to adjust their treatment, while another group will only be seen after three months. The aim is to see if this 'tight control' approach leads to quicker improvement and prevents the pain from becoming a long-term issue. Shoulder pain is very common and can stop people from doing daily activities and working, so finding better ways to manage it could make a big difference in reducing suffering and healthcare costs.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Nantes University Hospital
Enrolment target
156
Start
25 Nov 2024
Estimated completion
25 Nov 2027

What is this study about?

Shoulder pain is a really common problem that affects many people, especially those over 45. Often, this pain comes from issues with the 'rotator cuff,' which is a group of muscles and tendons around the shoulder joint. This pain can make it hard to do everyday things and can even affect your work, leading to time off.

Even though it's so common, doctors don't have clear, agreed-upon guidelines for the best way to manage this kind of shoulder pain. Many people still have pain a year or two later, so finding the best treatment early on is really important. This study wants to find out if keeping a close eye on patients with new rotator cuff pain – by seeing them more often – helps them recover quicker compared to the usual care.

Researchers believe that regular check-ups in the first few months will allow doctors to adjust treatments more quickly if needed. They hope this will lead to faster healing, prevent the pain from becoming a long-term problem, and reduce the overall costs associated with it, such as time off work and healthcare appointments.

Key takeaways

  • This study explores if more frequent doctor visits improve early shoulder pain.
  • It compares 'tight control' (monthly visits) with standard follow-up.
  • Looks at rotator cuff tendinopathy, a common type of shoulder pain.
  • Aims for faster recovery and reduced long-term problems.
  • Could help reduce healthcare costs and time off work.

Who may be eligible?

To be part of this study, you would need to be between 18 and 65 years old and have new shoulder pain that started less than six months ago. The pain should be related to a condition called rotator cuff tendinopathy, which means issues with the tendons around your shoulder. Your pain level also needs to be at a certain level to fit the study criteria.

You wouldn't be able to join if your shoulder pain is due to a recent injury like a dislocation or fracture, or if you've already had a steroid injection in that shoulder for this particular pain episode. People with other shoulder problems like inflammatory arthritis, a frozen shoulder, or certain tendon calcifications (calcium build-up) are also not eligible.

If you've had previous shoulder surgery, have a complete tear of a shoulder tendon, or are pregnant, you wouldn't be able to take part in this research either. The study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Do you have new shoulder pain (less than 6 months)?
  3. Is your pain likely from rotator cuff tendinopathy?
  4. Have you NOT had a steroid injection in this shoulder for this pain yet?
  5. Do you NOT have a recent serious injury or complete tendon tear in your shoulder?
  6. Are you NOT pregnant?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two groups by chance – like flipping a coin. One group will have a monthly check-up with a doctor for the first three months. The other group will have their first follow-up appointment after three months. At these appointments, the doctors will assess your pain and how well your shoulder is working, and treatment might be adjusted if needed. The total duration of your active participation, including follow-up, will be determined by the study protocol, but the initial intensive phase is three months.

Potential risks and benefits

Taking part in a study like this might offer the benefit of more frequent medical attention, which could potentially lead to quicker and more tailored adjustments to your treatment. This might help your recovery. However, there's also a chance that more frequent visits could be inconvenient. The study aims to inform better care for rotator cuff tendinopathy, which could help future patients. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

  • CHU Angers
    Verified postcode
    Angers, France· Recruiting
  • CHU de Brest
    Verified postcode
    Brest, France· Recruiting
  • CHRU de Tours
    Verified postcode
    Chambray-lès-Tours, France· Recruiting
  • CH Cholet
    Verified postcode
    Cholet, France· Recruiting
  • CH Vendée
    Verified postcode
    La Roche-sur-Yon, France· Recruiting
  • CH du Mans
    Verified postcode
    Le Mans, France· Recruiting
  • CHU de Nantes
    Verified postcode
    Nantes, France· Recruiting
  • Chotard Emilie
    Verified postcode
    Rennes, France· Recruiting

Common questions

What is rotator cuff tendinopathy?

It's a common condition where the tendons around your shoulder joint become irritated or inflamed, causing pain and difficulty moving your arm.

What does 'tight control management' mean?

It means having more frequent check-ups with your doctor, in this case, monthly for the first three months, so your treatment can be adjusted sooner if needed.

Will I get special medicine in this study?

The study focuses on how often you're seen by a doctor, not necessarily on a new medication. Treatments will follow standard care, adjusted based on your progress.

How long will the study last for me?

While the intensive phase for one group is three months of monthly visits, the overall follow-up period for the study will be explained in detail if you are eligible and interested.

What if my shoulder pain gets worse during the study?

Your medical team will monitor your condition, and if your pain worsens, they will provide appropriate care, and you can withdraw from the study at any time.

How to find out more

Christelle Darrieutort, PH

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Tight Control for Rotator Cuff Tendinopathy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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